Michael Bromby Reader in law Glasgow Caledonian University Brain Imaging: Consent Issues and Licensing of Storage and Analysis
Background Forensic brain imagine cannot (yet) be done Future developments in science Will the law then react appropriately? Can/should the law react in anticipation? Analogies to other intersections of science and law CCTV; human tissue; DNA
Is it like CCTV?
Is it like CCTV? MRI requires active participation No equivalent to covert surveillance Scans are not recognisable: by self by familiar others but can serve as an identifier by an expert
Is it like Human Tissue?
Is it like Human Tissue? Brain Internal organ Cellular material Scan Data creating an image Derived from human tissue
Legislation
Legislation Human Tissue Act 2004 England and Wales only Governs taking samples storing samples licensing
Legislation Human Tissue (Scotland) Act 2006 Scotland only Governs taking PM samples storing samples no licensing
What is Human Tissue?
What is Human Tissue? “ Relevant material” which consists of or includes  human cells Excludes: Cell lines Gametes Embryos Foetal tissue outside the body
What is Human Tissue? Excludes: Hair {Except where to be  Nail {used for DNA analysis What is…? Tissue extract  Cell sample   X-ray Biosample  Scrape MRI Biospecimen  Wipe fMRI Aspiration  Swab   SCAN? Bodily fluid  Graft Secretion  Shedding
Tissue Banks “ A collection of human tissue or other biological material, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending” NRES definition of a Research Tissue Bank
What is a Bank?! Biobank } Repository } Collection }May also include Registry }data such as medical Archive }notes and clinical outcomes Library } Etc. }
Licensing for Banks Run by Human Tissue Authority Powers to inspect Only for England and Wales Concerns collaborative projects in Scotland Not for diagnostic archives But required for prospective studies
Is it like DNA?
Is it like DNA? Not ‘bodily material’ legally speaking Scans are data Details inner-most self?
Is it like DNA? s45 of HTA 2004:  Non-consensual analysis of DNA (1) A person commits an offence if— (a) he has any bodily material intending— (i) that any human DNA in the material be analysed  without qualifying consent, and (ii) that the results of the analysis be used otherwise than  for an excepted purpose, (b) the material is not of a kind excepted under subsection (2), and (c) he does not reasonably believe the material to be of a kind so excepted.
Is it like DNA? DNA Profile Genetic information Genotype / Phenotype Brain Scan fMRI Functional information
Is it like DNA? DNA Profile Genetic information   FORM Genotype / Phenotype Brain Scan fMRI FUNCTION Functional information
Is it like DNA? DNA Profile Disease  Inheritance Genetic information   FORM Genotype / Phenotype Family Brain Scan Behaviour fMRI FUNCTION Functional information Intent Emotion
So What Should We Do? Legislate? Amend HTA to be wider? Create new  sui generis  law? Regulate? Licensing? Data protection principles?
So What Should We Do? Debate! What can/should we do? Where will it lead? Research! Create possibilities Consider implications
Thank You!

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Brain Imaging

  • 1. Michael Bromby Reader in law Glasgow Caledonian University Brain Imaging: Consent Issues and Licensing of Storage and Analysis
  • 2. Background Forensic brain imagine cannot (yet) be done Future developments in science Will the law then react appropriately? Can/should the law react in anticipation? Analogies to other intersections of science and law CCTV; human tissue; DNA
  • 3. Is it like CCTV?
  • 4. Is it like CCTV? MRI requires active participation No equivalent to covert surveillance Scans are not recognisable: by self by familiar others but can serve as an identifier by an expert
  • 5. Is it like Human Tissue?
  • 6. Is it like Human Tissue? Brain Internal organ Cellular material Scan Data creating an image Derived from human tissue
  • 8. Legislation Human Tissue Act 2004 England and Wales only Governs taking samples storing samples licensing
  • 9. Legislation Human Tissue (Scotland) Act 2006 Scotland only Governs taking PM samples storing samples no licensing
  • 10. What is Human Tissue?
  • 11. What is Human Tissue? “ Relevant material” which consists of or includes human cells Excludes: Cell lines Gametes Embryos Foetal tissue outside the body
  • 12. What is Human Tissue? Excludes: Hair {Except where to be Nail {used for DNA analysis What is…? Tissue extract Cell sample X-ray Biosample Scrape MRI Biospecimen Wipe fMRI Aspiration Swab SCAN? Bodily fluid Graft Secretion Shedding
  • 13. Tissue Banks “ A collection of human tissue or other biological material, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending” NRES definition of a Research Tissue Bank
  • 14. What is a Bank?! Biobank } Repository } Collection }May also include Registry }data such as medical Archive }notes and clinical outcomes Library } Etc. }
  • 15. Licensing for Banks Run by Human Tissue Authority Powers to inspect Only for England and Wales Concerns collaborative projects in Scotland Not for diagnostic archives But required for prospective studies
  • 16. Is it like DNA?
  • 17. Is it like DNA? Not ‘bodily material’ legally speaking Scans are data Details inner-most self?
  • 18. Is it like DNA? s45 of HTA 2004: Non-consensual analysis of DNA (1) A person commits an offence if— (a) he has any bodily material intending— (i) that any human DNA in the material be analysed without qualifying consent, and (ii) that the results of the analysis be used otherwise than for an excepted purpose, (b) the material is not of a kind excepted under subsection (2), and (c) he does not reasonably believe the material to be of a kind so excepted.
  • 19. Is it like DNA? DNA Profile Genetic information Genotype / Phenotype Brain Scan fMRI Functional information
  • 20. Is it like DNA? DNA Profile Genetic information FORM Genotype / Phenotype Brain Scan fMRI FUNCTION Functional information
  • 21. Is it like DNA? DNA Profile Disease Inheritance Genetic information FORM Genotype / Phenotype Family Brain Scan Behaviour fMRI FUNCTION Functional information Intent Emotion
  • 22. So What Should We Do? Legislate? Amend HTA to be wider? Create new sui generis law? Regulate? Licensing? Data protection principles?
  • 23. So What Should We Do? Debate! What can/should we do? Where will it lead? Research! Create possibilities Consider implications